Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur – 416 013, M. S., India
*Corresponding Author E-mail: swapnil.jadhav@bharatividyapeeth.edu
Online published on 19 June, 2014.
The Tenofovir Disoproxil, Ferrous, Bisoprolol and Ketotifen were used in marketed formulations in the form of fumaric acid salt due to stability and solubility purposes. Stability of marketed formulation is an important aspect that needs special attention over the period of time. Designing of colorimetric reagent (3, 5 Dinitro Benzoic Acid) and development of analytical method has been carried out for estimation of fumaric acid from marketed formulations which indirectly quantifies Bisoprolol and Ketotifen. The fumaric acid shows linearity in concentration range of 100–700 ng/mL. The result of analysis of marketed formulation of Bisoprolol and Ketotifen we found to be within 98.00 to 102% with RSD value of less than 2%. The forced degradation studies of Bisoprolol and Ketotifen was carried out which shows degradation less than 20% and results were accurate and precise. The method was validated using ICH Q2B (R1) guidelines. The method was found to be simple, accurate, precise, sensitive and selective.
